Advanced Esophagogastric cancer.
Conditions
Interventions
Group A:
patients will be treated with gemcitabine 1250 mg/m2 IV on days 1 and 8 in combination with Cisplatin 80 mg/m2 on day 1 with vitamin supplementation (Folic acid 450 ìg/24h PO, starting at le
Sponsors
Vu Medical center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must have histologically or cytological confirmed metastatic or locally advanced unresectable advanced esophagogastric carcinoma (squamous or adenocarcinoma), not amenable for curative treatment. 2. Patients may have received prior surgery, and chemotherapy and/or radiotherapy in neo-adjuvant or adjuvant setting as long as the chemotherapy was completed at least 6 months prior to study entry. 3. Patients should have measurable disease according to RECIST Criteria. 4. Age of at least 18. 5. Performance status (ECOG) 0, 1 or 2. 6. Life expectancy of at least 12 weeks. 7. Adequate bone marrow function, defined by a neutrophil count above 1.5 x 109/L, platelet count above 100 x 109/L and hemoglobin above 5,6 mmol/L. 8. Adequate renal and hepatic function, defined by bilirubin £ 1.5 x upper limit of normal (ULN), alkaline phosphatase (AP), Aspartate transaminase (AST) and alanine transaminase (ALT) 60mL/min ( calculated by using the Cockcroft and Gault formula. 9. Patients must not already be taking vitamin supplements as defined in the protocol. 10. Patients with childbearing potential must use an adequate contraceptive method. 11. Patients must be able to comply with protocol procedures, able to swallow pills and have adequate geographical proximity to the study site. 12. Patients must sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Active infection or cardiac disease, at the investigator’s criteria. 2. Pregnancy or breast-feeding. 3. Known symptomatic metastasis in the central nervous system (CNS). 4. Treatment with any investigational agent in the month prior to inclusion. 5. Other serious disease, at the investigator’s discretion. 6. Prior diagnosis of other malignant disease, excluding adequately treated in situ carcinoma of the cervix and skin cancer other than melanoma, low grade prostate carcinoma (gleason score < 6) or any other non-relapsed malignancy that was treated more than five years before diagnosis. 7. Received any RBC transfusions within 14 days before first dose of Aranesp or received rHuEPO or darbepoetin alfa therapy within 4 weeks before study day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression, overall survival. | — |
Contacts
Public ContactN. Groeningen, van
VU University Medical Center, Department of Medical Oncology, 3 A 20, P.O. Box 7057
Outcome results
None listed